Probe Assesses Engraftment in Sex-Mismatched Transplants

DOWNERSGROVE, Ill--Vysis, Inc. has received FDA clearance to market its CEP XSpectrumOrange/CEP Y SpectrumGreen DNA Probe Kit, an in vitro diagnosticused as an adjunct to standard cytogenetic analysis to identify and enumeratethe presence of X and Y chromosomes in bone marrow specimens from patientswho have received sex-mismatched bone marrow transplants.

The probe is used to assess the success of engraftment after transplantand to diagnose recurrence. CEP X/Y allows visualization of the sex chromosomesin a procedure that provides results in less than three hours, thus providinga presumptive diagnosis before standard cytogenetic analysis.

The approval is the company's third in two months for its in vitro diagnosticFISH probes for leukemia. The other products are the CEP 8 Spectrum-OrangeDNA Probe Kit, used to detect trisomy 8, a key prognostic indicator forleukemia and other myeloid disorders, and the CEP 12 Spectrum-Orange DNAProbe Kit, used to detect trisomy 12, a common chromosomal alteration inCLL patients.